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Vaccine Update

Vaccine Update. William Atkinson, MD, MPH* Idaho Immunization Conference Boise, Idaho September 30 2013. *Representing the Immunization Action Coalition, Saint Paul, MN. Disclosures.

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Vaccine Update

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  1. Vaccine Update William Atkinson, MD, MPH* Idaho Immunization Conference Boise, Idaho September 30 2013 *Representing the Immunization Action Coalition, Saint Paul, MN

  2. Disclosures • William Atkinson has no financial conflict or interest with the manufacturer of any product named during this presentation • The speaker will discuss the use of Tdap and HPV vaccines in a manner not approved by the Food and Drug Administration (FDA) but recommended by ACIP • The speaker will not discuss vaccines not licensed by the FDA

  3. Disclosures • The recommendations to be discussed are primarily those of the Advisory Committee on Immunization Practices (ACIP) • composed of 15 experts in clinical medicine and public health who are not government employees • provides guidance on the use of vaccines and other biologic products to the Department of Health and Human Resources, CDC, and the U.S. Public Health Service www.cdc.gov/vaccines/recs/acip/

  4. What’s New in Immunization • 2013 schedules • Influenza vaccine • Tdap in pregnancy • Meningococcal vaccines • HPV vaccines • Vaccine hesitancy

  5. 2013 Immunization Schedules • Published in MMWR on February 1, 2013 • Childhood, adolescent and adult schedules published together for the first time • Childhood and adolescent schedules merged (separate schedules since 2007) • Footnotes consolidated • Download schedules from CDC website www.cdc.gov/vaccines/schedules/

  6. Influenza Vaccine Abbreviations • TIV (Trivalent Inactivated Influenza Vaccine) replaced with IIV (Inactivated Influenza Vaccine): • IIV refers to inactivated vaccines (egg and cell-culture based) • Includes trivalent (IIV3) and quadrivalent (IIV4) vaccines; • Where necessary, cell-culture-based IIV is referred to as ccIIV/ccIIV3; • RIV refers to recombinant HA influenza vaccine • Trivalent (RIV3) for 2013-14; • LAIV refers to Live Attenuated Influenza Vaccine • Quadrivalent (LAIV4), for 2013-14).

  7. Influenza Vaccine Virus Strains for 2013-14 • Trivalent vaccines will contain: • An A/California/7/2009 (H1N1)-like virus, • An H3N2 virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011, and • AB/Massachusetts/2/2012-like virus (Yamagata lineage) • Quadrivalent vaccines, will contain, in addition: • AB/Brisbane/60/2008-like virus (Victoria lineage)

  8. Recently-approved Influenza Vaccines • Quadrivalent influenza vaccine, live attenuated (LAIV4): • Flumist Quadrivalent (MedImmune) • Quadrivalent influenza vaccines, inactivated (IIV4): • Fluarix Quadrivalent (GSK) • Fluzone Quadrivalent (Sanofi Pasteur) • Cell culture-based influenza vaccine (ccIIV3): • Flucelvax (Novartis) • Recombinant hemagglutinin (HA) vaccine (RIV3): • FluBlok (Protein Sciences) www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093830.htm

  9. Quadrivalent Influenza VaccinesRationale • Two lineages of influenza B viruses: Victoria and Yamagata • Immunization against virus from one lineage provides only limited cross-protection against viruses in the other • Trivalent vaccines contain only one B vaccine virus • Only one B lineage is represented • Predominant lineage is difficult to predict in advance of the season • Quadrivalent vaccines contain one virus from each B lineage

  10. Flumist Quadrivalent (LAIV4) (MedImmune) • Will replace trivalent LAIV starting 2013-14 • Same presentation (intranasal sprayer) and administration • Recommendations same as those for trivalent LAIV • Healthy, non-pregnant persons aged 2-49 years • Similarly immunogenic to LAIV3 • No preferential recommendation for LAIV vs. IIV where either is otherwise appropriate • Acceptable alternative to other licensed products used within indications and recommendations

  11. Fluarix Quadrivalent (IIV4) (GSK) • Approved for persons aged 3 years and older • Available in 0.5mL prefilled syringes for IM injection • Both Fluarix (IIV3) andFluarix Quadrivalent (IIV4) available • Likely more IIV3 available than IIV4 during 2013-14 • Similarly immunogenic to trivalent • Acceptable alternative to other licensed products used within indications and recommendations

  12. Fluzone Quadrivalent (IIV4) (sanofi) • Approved for persons aged 6 months and older • Three different presentations, all for IM injection • 0.25 mL prefilled syringes for 6 through 35 months • Also in 0.5mL syringes and 0.5 mL vials • Both Fluzone (IIV3) and Fluzone® Quadrivalent (IIV4) will be available • Likely more IIV3 available than IIV4 in 2013-14 • Similarly immunogenic to trivalent • Acceptable alternative to other licensed products used within indications and recommendations

  13. Influenza Vaccine Preference • ACIP has not stated a preference for quadrivalent or trivalent influenza vaccine in any age or risk group • All influenza vaccines should be used only in the age group approved by the Food and Drug Administration

  14. Vaccines Produced via Non-Egg-Based Technologies • May permit more rapid scale up of vaccine production (e.g., as might be needed during a pandemic) • Two vaccines this season, both trivalent: • Cell culture-based • Recombinant hemagglutinin (HA)

  15. Flucelvax (ccIIV3) (Novartis) • Approved for persons aged 18 and older • Vaccine virus propagated in Madin Darby Canine Kidney cells • Available in 0.5mL single dose vials for IM injection • Vaccine viruses for ccIIV are not propagated in eggs; however, initial reference strains have been passaged in eggs • cannot be considered egg-free, though expected to contain less egg protein than other IIVs • Acceptable alternative to other licensed products used within indications and recommendations

  16. FluBlok (RIV3) (Protein Sciences) • Approved for persons aged 18 through 49 years • Vaccine contains recombinant influenza virus hemagglutinin • Protein is produced in insect cell line • No eggs or influenza viruses used in production • Available in 0.5mL single-dose vials for IM injection • Egg-free • Acceptable alternative to other licensed products used within indications and recommendations

  17. Other Vaccines Available for 2013-14 • Standard dose IIVs (multiple brands) • For persons age 6 months and older, BUT age indications differ by brand • High dose IIV (Fluzone High Dose)—65 yrs. and over • Intradermal IIV (Fluzone Intradermal)—18 through 64 yrs. • ACIP currently expresses no preferences

  18. Can the individual eat lightly cooked egg (e.g., scrambled egg) without reaction?*† Administer vaccine per usual protocol Yes Yes Yes No No Influenza Vaccination for Persons with Egg Allergies—2011-12 and 2012-13 Administer IIV Observe for reaction for at least 30 minutes following vaccination After eating eggs or egg-containing foods, does the individual experience ONLY hives? • After eating eggs or egg-containing foods, does the individual experience other symptoms such as: • Cardiovascular changes (e.g., hypotension) • Respiratory distress (e.g., wheezing) • Gastrointestinal (e.g., nausea/vomiting) • Reaction requiring epinephrine • Reaction requiring emergency medical attention Refer to a physician with expertise in management of allergic conditions for further evaluation

  19. Can the individual eat lightly cooked egg (e.g., scrambled egg) without reaction?*† Administer vaccine per usual protocol Yes Yes Yes No No Influenza Vaccination for Persons with Egg Allergies—2013-14:First Modification Administer RIV3, if patient aged 18 through 49 yrs.; OR Administer IIV Observe for reaction for at least 30 minutes following vaccination After eating eggs or egg-containing foods, does the individual experience ONLY hives? • After eating eggs or egg-containing foods, does the individual experience other symptoms such as: • Cardiovascular changes (e.g., hypotension) • Respiratory distress (e.g., wheezing) • Gastrointestinal (e.g., nausea/vomiting) • Reaction requiring epinephrine • Reaction requiring emergency medical attention Administer RIV3, if patient aged 18 through 49 yrs.; OR Refer to a physician with expertise in management of allergic conditions for further evaluation

  20. Influenza Vaccination for Persons with Egg Allergies—2013-14: Second Modification • Addition of the following: • For individuals with no known history of exposure to egg, but who are suspected of being egg-allergic on the basis of previously performed allergy testing: • Consultation with a physician with expertise in the management of allergic conditions should be obtained prior to vaccination • Alternatively, RIV3 may be administered if the recipient is aged 18 through 49 years

  21. One Dose or Two? Vaccine for Children 6 Months Through 8 Years • Children aged 6 months through 8 years require 2 doses in first season they are vaccinated • If previously vaccinated, need to have received 2009(H1N1)-containing vaccine (2009 monovalent, or 2010-11, 2011-12, or 2012-13 seasonal vaccines) • This season (as the last), there are two acceptable approaches for determining the number of doses • These differ in whether or not vaccination history prior to the 2010-2011 season is considered MMWR 2012; 61(32):613-618.

  22. Dose algorithm for 6mo through 8yr olds,2013-14 season—First approach * Doses should be administered a minimum of 4 weeks apart. MMWR 2012; 61(32):613-618.

  23. Dose algorithm for 6mo through 8yr olds,2013-2014 season—Alternative approach • If vaccination history before 2010–11 is available • If child received • ≥2 seasonal influenza vaccines during any previous season, • And ≥1 dose of a 2009(H1N1)-containing vaccine (monovalent 2009(H1N1) or 2010-11, 2011-12 or 2012-13 seasonal vaccine), • Then the child needs only 1 dose in 2013–14. • Children 6mos—8yrs for whom this is not the case need 2 doses • Need only 1 dose of vaccine in 2013–14 if : • ≥2 doses of seasonal influenza vaccine since July 1, 2010; or • ≥2 of seasonal influenza vaccine before July 1, 2010, and ≥1 dose of monovalent 2009(H1N1) vaccine; or • ≥1 dose of seasonal influenza vaccine before July 1, 2010, and ≥1 dose of seasonal influenza vaccine since July 1, 2010. MMWR 2012; 61(32):613-618.

  24. Source: www.cdc.gov/flu/pdf/fluvaxview/hcp-ips-nov2012.pdf Health Care Personnel and Influenza Vaccination 2020 Healthy People Goal is 90% Lowest among assistants/ aides (43.4%) and administrative/non-clinical support staff (54.5%)

  25. H7N9 Avian Influenza • First human infections - 132 cases and 37 deaths* most from Shanghai and all from China • Most cases believed to have had contact with birds • No evidence of sustained person-to-person transmission • Aggressive control measures since April 2013 *as of May 30, 2013

  26. Pertussis in the U.S. – 2012 • Nationwide – provisional 2012 • 41,880 reported cases • More than twice as many cases as in 2011 year (2011=18,719) • Several outbreaks or increased activity in several states in 2012 • 17 deaths reported (14 among infants less than 3 months of age) • 12,424 cases reported in 2013 (as of August 4) CDC unpublished data, www.cdc.gov/pertussis/outbreaks.html MMWR 61 (37) ND-516

  27. Pertussis-Containing Vaccines • DTaP (pediatric) • Approved for ages 6 weeks through 6 years • 3 doses needed for protection • Tdap (adolescents and adults) • Boostrix (GlaxoSmithKline) - approved for persons 10 years of age and older • Adacel (sanofipasteur) - approved for persons ages 11 through 64 years • Neither approved by FDA for persons 7 through 9 years of age • Both approved as a single booster dose

  28. Pertussis Vaccine Effectiveness • DTaP • Very good short-term protection • Effectiveness wanes over time • Even modest waning, with high exposure, can result in • Infection of vaccinated children • Increase rates of disease in communities • Tdap • Despite high adolescent vaccination rates, a lot of disease in this age group • Effectiveness and duration of protection being evaluated

  29. Adolescent Tdap Recommendations • Routinely recommended at 11 - 12 years of age • Catch up 13 through 18 years who have not been vaccinated with Tdap • Children 7 through 10 years who are not “fully vaccinated against pertussis”* • “fully vaccinated against pertussis” is • 5 doses of DTaP, or • 4 doses of DTaP if the fourth dose was administered on or after the fourth birthday *Off-label recommendation. MMWR 2011; 60 (No. 1):13-5

  30. Adult Tdap Recommendations • Administer Tdap to unvaccinated adults 19 years and older including adults over 65 years of age* • Tdap should be administered as soon as feasible to unvaccinated • healthcare personnel with direct patient contact • close contacts of infants younger than 12 months of age, including unvaccinated postpartum women *Off-label recommendation for Adacel. MMWR 2011; 60 (No.41):1);1424-1426

  31. Tdap - Additional Information • There is no minimum interval between the last dose of tetanus toxoid-containing vaccine and a dose of Tdap • If possible, Boostrix should be used for adults 65 years of age and older • Administer Adacel* if Boostrix is not available *Off-label recommendation. MMWR 2011; 60 (No.1):13-5

  32. Tdap and Pregnant Women • Administer a dose of Tdap vaccine to during each pregnancy irrespective of the woman’s prior history of receiving Tdap* • To maximize passive transfer of antibody to the fetus optimum timing of Tdap is between 27 and 36 weeks gestation • Tdap may be administered earlier in pregnancy if necessary (e.g. wound management) *Off-label recommendation. MMWR 2013:62( (No.7): 131-135

  33. Meningococcal Disease Incidence, United States, 1970-2011 1970-1996 NNDSS data, 1997-2011 ABCs data estimated to U.S. population with 18% correction for under reporting *In 2010, estimated case counts from ABCs were lower than cases reported to NNDSS and may not be representative

  34. Meningococcal Vaccines Vaccine Type Age • Menomune PS 2 yrs and older • Menactra Conj 9 mos – 55 yrs • MenveoConj 2 mos* – 55 years • MenHibrixConj 6 wks – 18 mos *as of August 1, 2013

  35. Meningococcal Vaccine Recommendations • Routine vaccination of adolescents at 11-12 years with booster dose at 16 years • Routine vaccination persons 2 months and older at increased risk of meningococcal disease • Medical conditions (asplenia, complement deficiency) • Previously unvaccinated first-year college students living in a resident hall <22 years of age • Military recruits • Microbiologists • Persons 9 months and older who travel or live in endemic areas

  36. HibMenCY (MenHibrix) (GSK) • Approved by FDA in June 2012 • Contains Haemophilusinfluenzaetype b and Neisseria meningitidis serogroups C and Y polysaccharides conjugated to tetanus toxoid • Approved for 4 doses among children 6 weeks through 18 months of age • Approved schedule is doses at 2, 4, 6 and 12 through 15 months of age

  37. Meningococcal Vaccine Recommendations • ACIP does not recommend routine meningococcal vaccination of infants • Infants at increased risk for meningococcal disease should be vaccinated with 4 doses of HibMenCY (or Menveo?*) • persistent complement pathway deficiencies • anatomic or functional asplenia including sickle cell disease • HibMenCY(or Menveo?*) can be used in infants ages 2 through 18 months who are in communities with meningococcal disease outbreaks *ACIP has not made a recommendation on the use of Menveo in children

  38. Human Papillomavirus (HPV) • 20 million currently infected • Half of infections are among persons 15 through 24 years of age • Infection occurs soon after sexual debut • Most sexually active adults become infected at some point in their life • Most severe disease occurs from persistent infection

  39. HPV-Associated Cancers in the United States • 33,369 HPV-associated cancers diagnosed annually (2004-2008) • 12,080 men • 21,290 women American Cancer Society. www.cancer.org/acs/groups/. Gillison ML, et al. Cancer. 2008;113(10 Suppl) 3036-3046; MMWR 2012;61:268-261

  40. HPV Immunization Rates*, NIS-Teen, 2011Females13-17 Years of Age *Percentages 1 or more human papillomavirus vaccine doses, either HPV4 or HPV2 reported among females only (n=9,220) ** Percentage of females who received 3 doses among those who had at least 1 HPV dose and at least 24 weeks between the first dose and interview date MMWR 2012; 61 (No. 34): 671- 677

  41. Healthy People 2020 Objectives Actual and Potentially Achievable Vaccination Coverage if Missed Opportunities Were Eliminated: NIS-Teen, 2011 HPV-1 coverage is among females only. Source: NIS Teen 2011; Slide courtesy Shannon Stokley (CDC/NCIRD/ISD)

  42. Pediatrics 2013;131:645–651

  43. ACIP HPV Vaccine Recommendations • 2 products: HPV2 (Cervarix) and HPV4 (Gardasil) • Approved for ages: 9 through 26 years* • Both products are a 3 dose series • Schedule*: • Administer the 2nd dose 1-2 months after dose 1 • Administer the 3rd dose 6 months (24 weeks) after dose 1 and at least 12 weeks after dose 2 *Off-label recommendation. Cervarix FDA approved 9 – 25 yrs. MMWR; (59)20; 626-629

  44. ACIP HPV Vaccination Recommendations Females • Routine: 11 or 12 years • Catch-up: 13 through 26 years • Administer HPV4 or HPV2 Males • Routine: 11 or 12 years • Catch-up: • 13 through 21 yrs All • 22 through 26 years • Immunocompromised • HIV infected • MSM • Healthy men: 22 -26 years may be vaccinated • Administer HPV4 only MMWR 2011;60(No. 50):1705-8.

  45. Strategies for Increasing HPV Vaccination Rates in Clinical Practice • Recommend HPV vaccine! • Include HPV vaccine when discussing other needed vaccines • Integrate standard procedures supporting vaccination • Assess for needed vaccines at every clinical encounter • Immunize at every opportunity • Standing orders • Reminder and recall • Tools for improving uptake of HPV: www.cdc.gov/vaccines/teens

  46. Causes of Parent/Guardian Vaccine Hesitancy • “Lifestyle” issues • Political issues • Fear of side effects • No vaccine has ever been shown to cause autism, SIDS, or any other chronic condition

  47. Children With Personal Belief Exemption • 9-fold higher risk of varicella (Colorado, 1998-2008) • 23-fold higher risk of pertussis (Colorado, 1996-2007) • Introduce vaccine-preventable diseases (particularly measles) into school settings • Expose children with medical exemptions to infection

  48. Personal Belief Exemptions • Permitting personal belief exemptions and easily granting exemptions are associated with higher and increasing nonmedical U.S. exemption rates • State policies granting personal belief exemptions and states that easily grant exemptions are associated with increased pertussis incidence JAMA. 2006;296:1757-1763

  49. Reducing Vaccine Hesitancy and Personal Belief Exemptions • Engage the parent and answer their questions if possible • Be sure the parent understands that unvaccinated students will be excluded from school in the event of an outbreak • Provide the parent with information • Suggest reliable websites for further information (some are listed on IAC “What If” fact sheet)

  50. CDC Vaccines and ImmunizationContact Information Telephone 800.CDC.INFO (for patients and parents) Email nipinfo@cdc.gov (for providers) Website ww.cdc.gov/vaccines/ Vaccine Safety www.cdc.gov/vaccinesafety/

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